Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Rayner Surgical (Ireland) Limited, The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland, Tel +353 (0) 860592303, Fax +44 (0) 1903 751 470, Email GerKemmy@rayner.com
Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for intraocular irrigation. Clear, colourless to slightly yellow, solution with a pH: 6.3 ±0.3. |
Each 4 mL of concentrate for solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac.
After dilution in 500 mL of irrigation solution, the solution contains 0.081 mg/mL of phenylephrine and of 0.023 mg/mL ketorolac.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ketorolac |
Ketorolac is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. Ketorolac inhibits the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins. Ketorolac has been shown to reduce prostaglandin levels in the aqueous humour after topical ophthalmic administration. |
|
| Phenylephrine |
Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
Colourless 5 mL type I glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap. Each single-use vial is packaged in a cardboard carton.
Pack size: multipack containing 10 (1 pack of 10) single-use vials.
Rayner Surgical (Ireland) Limited, The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland, Tel +353 (0) 860592303, Fax +44 (0) 1903 751 470, Email GerKemmy@rayner.com
EU/1/15/1018/001
Date of first authorisation: 28 July 2015
Renewal date: 23 July 2020
| Drug | Countries | |
|---|---|---|
| OMIDRIA | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United States |
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